| CTRI Number |
CTRI/2020/04/024531 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the results of Shaivaladya Ghrita and Yashtimadhu Ghrita in the patients suffuring from Acute Fissure in Ano (A tear in anal canal) |
|
Scientific Title of Study
|
A Comparative Clinical Trial of Shaivaladya Ghrita and Yashtimadhu Ghrita Application in the Management of Parikartika W.S.R. to Acute Fissure-in-Ano
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham khare |
| Designation |
PG-Scholar |
| Affiliation |
Parul institute of ayurveda |
| Address |
Parul institute of ayurveda department of shalya tantra 4th floor room no 403 parul university limda vadodara gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
9424422043 |
| Fax |
0 |
| Email |
skhare1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrParikshit shirode |
| Designation |
Professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
Parul institute of ayurveda department of shalya tantra 4th floor room no 403 parul university limda vadodara gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
9960063588 |
| Fax |
|
| Email |
parikshit.shirode260038@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrParikshit shirode |
| Designation |
Professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
Parul institute of ayurveda department of shalya tantra 4th floor room no 403 parul university limda vadodara gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
9960063588 |
| Fax |
|
| Email |
parikshit.shirode260038@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurveda
parul university limda vadodara |
|
|
Primary Sponsor
|
| Name |
Parul institute of ayurveda |
| Address |
Parul institute of ayurveda parul university po limda Vadodara |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr shubham khare |
Parul ayurved hospital |
Ground floor OPD no, 116 department of shalyatantra parul ayurved hospital po limda vadodara
Vadodara
GUJARAT |
9424422043
skhare1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research, Parul institute of ayurveda, Parul university |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shaivaladya Ghrita application in Acute Fissure in Ano |
• Duration of Treatment:
Shaivaladya Ghrita will be applied for 10 days.
Dose:
Shaivaladya Ghrita will be applied twice a day.
Each sitting will contain 05 ml of Shaivaladya Ghrita which will be pushed in anus with the help of syringe and catheter .
Follow up And Observation period:
The patients will be observed and assessed on 1st, 3rd, 5th, 7th and 10th day.
Follow up of the patient will be carried out on the 15th & 30th day. |
| Comparator Agent |
Yashtimadhu Ghrita application in Acute Fissure in Ano |
Duration of Treatment:
Yashthimadhu Ghrita will be applied for 10 days.
Dose:
Yashthimadhu Ghrita will be applied twice a day.
Each sitting will contain 05 ml of Yashthimadhu Ghrita which will be puished in anus with the help of syringe and catheter.
Follow up And Observation period:
The patients will be observed and assessed on 1st, 3rd, 5th, 7th and 10th day.
Follow up of the patient will be carried out on the 15th and 30th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from Parikartika (Acute fissure-in-ano) with symptoms of Painful defecation, burning sensation, bleeding per rectum i.e. stools streaked with blood, constipation, spasm of the sphincter.
2. Patient having solitary and multiple anal fissures.
3. Pregnant women and Post partum patients.
4. Patient within the age group of 18 to 70 years of age.
5. Patients will be selected irrespective of cast and religion, gender, habitat, occupation and socio- economic status. |
|
| ExclusionCriteria |
| Details |
1. Chronic fissure-in-ano.
2. Patients having parikartika (Fissure-in-Ano) secondary to known case of Ulcerative colitis, Crohn’s disease, Syphilis and Tuberculosis, Malignancy will be excluded. 3. Patient below 18 years of age.
4. Patient with infective wound at anal region. 5. HIV and hepatitis B.
6. Uncontrolled diabetes mellitus |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shaivaladya Ghrita will be more effective than Yashtimadhu Ghrita in the management of parikartika in 10 days in Indian Population |
Shaivaladya Ghrita will be more effective than Yashtimadhu Ghrita in the management of parikartika in 10 Days in Indian Population |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nill |
nill |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Parikartika(Fissure-in-ano) is the commonest anorectal condition seen in the day-to-day practice. Recent statistics reveals that more than 80% of population suffers from this disease. In this condition the Constipation and Mandagni are the prime causative factors 2.Acharya Dalhana has described the parikartika as a condition in which there is cutting and tearing pain in Guda. The factors responsible for causation of Parikartika as found in various texts are Vamana-Virechana-Vyapada, Bastikarma Vyapada, Atisara, Grahani, Arsha, Udavarta etc. 3.The common causes for Fissure-in-Ano are trauma to the anal canal due to hard stool and spasm of internal sphincter. The disease is also secondary to systemic conditions like ulcerative colitis, Crohn’s disease, tuberculosis, etc. The disease also manifests as a delayed complication of surgical procedures like Haemorrhoidectomy and Fistulectomy. 4. In present modern science many treatment modalities are available, but all are temporarily effective, and with less or more side effects. 5.So the Shaivaladya Ghrita is selected for the clinical trial in the management of Parikartika (Acute fissure-in-Ano) to find fast, soothing, long term and fruitful remedy. |